Kornimate/medical-research-clean huggingface dataset:
using virtual reality to treat social anxiety in autistic adolescents

Conditions: Autism Spectrum Disorder; Social Anxiety

Summary: this study will test the feasibility and acceptability of virtual reality assisted cognitive behavioural therapy for the treatment of social anxiety in autistic adolescents. five adolescents will receive the intervention and a parent/caregiver of each adolescent will be asked to act as informants on some questionnaires and interviews.

difficulties interacting with others in social situations is a core characteristic of autism spectrum disorder (asd). these difficulties are intensified by social anxiety - commonly experienced in autistic adolescents. a promising psychological treatment is cognitive behavioural therapy (cbt), but there are constraints in its use for the autistic population. for example, cbt requires patients to imagine being in a social situation that would cause anxiety, but autistic people often experience difficulties with imagination. the use of virtual reality (vr) in cbt may help to lessen such constraints. vr uses 3d computer-generated visual environments displayed through a head-mounted display. the images are synchronised to the movements of the user such that they experience feeling immersed in the virtual scene. the virtual scene can involve social scenarios, making it an ideal tool for eliciting social anxiety in the treatment setting. the investigators can see if these virtual scenarios are indeed eliciting social anxiety by recording physiological responses (e.g. heart rate) in parallel with patients' anxiety ratings during exposure. this is important for cbt to be effective. this study will test the feasibility and acceptability of vr-assisted cbt, combined with the use of physiological measurements, in autistic adolescents experiencing social anxiety. the therapy will typically consist of 8-20 weekly sessions and will be delivered by clinical psychologists in local mental health services. conventional outcome measures will be used and feedback from youth and their parents/caregivers will be requested. the results of this study may lead to modification of the treatment and research methods. they will inform a later pilot randomised controlled trial.

Eligibility criteria:
inclusion criteria: participants will be included at screening if: * aged between 13 and 18 years * clinically diagnosed with asd by a neurodevelopmental clinician * experiencing anxiety in social situations that is impairing daily functioning as determined by clinicians * deemed suitable by the clinical team for the intervention based on factors such as sufficient verbal ability, desire to participate, willingness to undertake exposure-based activities, and no current/active suicidal plans. * able to speak and understand english fluently * patient and parents/caregivers agree to cbt exclusion criteria: participants will be excluded at screening if: * diagnosed with photosensitive epilepsy * receiving concurrent psychological therapy * immediate plans are in-place to change their psychopharmacological medication regimen

Keywords: social phobia anxiety
microbiota-anastomotic leak among colorectal surgery patients : pilot study

Conditions: Colorectal Cancer; Inflammatory Bowel Diseases; Microbiota; Anastomotic Leak

Summary: the study is based on the hypothesis that patients with postoperative anastomotic leakage have a different bacterial profile contributing to poor tissue healing, and that patients operated for colon cancer presumably have a different preoperative microbiota than healthy patients. this different composition is probably induced by the high heme level in the light intestinal tract that tumor spoliation generates. the objective of the study is to evaluate the feasibility of a larger study to evaluate the difference between microbiota composition of patients with and without colorectal cancer, with inflammatory bowel disease and those with and without anastomotic leakage postoperatively of a colonic resection. stool samples will be taken from 20 patients, including 5 without intestinal pathology, 5 with colorectal cancer undergoing colorectal surgery, 5 with inflammatory bowel disease and 5 with anastomotic leakage after colectomy for colorectal cancer or inflammatory bowel disease. the stool samples will be analyzed at crchum to draw up a profile of the bacteria that make up the microbiota of each patient.

no more details required.

Eligibility criteria:
inclusion criteria: all * informed consent obtained. * between 18 to 90 years old inclusive. * group 1 (colorectal cancer patients) * patients with colorectal cancer confirmed with pathology results. * oncological colon and / or rectal resection planned and performed by a surgeon from the digestive surgery department of the chum. * group 2 (anastomotic leak patients) * patients with colorectal cancer confirmed with pathology and / or patients with inflammatory bowel disease. * patients who underwent colonic and / or rectal surgical resection, complicated by an anastomotic leak in the postoperative period. * group 3 ("healthy" patients) * patients with uncomplicated hernia pathology assessed externally in anticipation or after hernia repair surgery that does not involve gastrointestinal resection. * patients with no history of colorectal neoplasia or surgical resection of the gastrointestinal tract. * group 4 (inflammatory bowel disease patients) * patients with inflammatory bowel disease (ibd), waiting for elective surgery involving gastrointestinal resection. exclusion criteria: * pregnancy. * class of the american society of anesthesiologists (asa)\> 3. * chemotherapy and / or pelvic and / or abdominal radiotherapy within 6 months prior to collection of the stool sample prior to surgery (group 3 with healthy patients only). * colonoscopy within 3 months prior to collection of the stool sample prior to surgery (group 3 with healthy patients only).
service dogs for veterans with ptsd

Conditions: PTSD

Summary: the purpose of this study is to evaluate use of service dogs for individuals who have been diagnosed with post traumatic stress disorder (ptsd). objectives include: (1) assess the impact service dogs have on the mental health and quality of life of veterans; (2) to provide recommendations to the va to serve as guidance in providing service dogs to veterans; and (3) to determine cost associated with total health care utilization and mental health care utilization among veterans with ptsd.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * referral from provider. * ptsd diagnosis * in active treatment for ptsd for at least three months at time of enrollment, with plans to remain in active treatment * acceptance by the dog vendor for the service dog * ability to adequately care for a dog - physically/financially * able to travel to vendor for pairing with dog exclusion criteria: * been hospitalized for mental health reasons in the prior 6 months * not living at the same residence for 6 months. * diagnoses: psychoses, delusions, dementia, active alcohol/substance dependence. moderate to severe tbi. any other diagnosis deemed by pi to limit ability to participate or give informed consent * at time of enrollment - active suicidal ideation, homicide, cognitive disabilities that would preclude safety of animal and ability needed for participation in the study. * children under age 10 living in the home

Keywords: ptsd service dogs
po vs. iv acetaminophen given perioperatively for 24 hr post-op pain control following total hip or knee replacement

Conditions: Post-op Pain

Summary: the purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either oral acetaminophen or iv acetaminophen

subjects will be randomized to receive perioperative dosing of either: 1. oral acetaminophen (tylenol) 1000mg with iv placebo (100ml normal saline), or, 2. iv acetaminophen (ofirmev) 1000mg/100ml with oral placebo (oral capsules). subject pain levels and post-operative opioid use will be tracked for up to 24 hours after surgery.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * able to provide written consent * able to read and write in english * weighing over 50 kg * will undergo total hip or total knee joint replacement exclusion criteria: * non-verbal patients * unable to use numeric pain scale * allergic to the test article * documented hepatic impairment or failure * current illicit drug use * requires traumatic or emergent surgery * pregnant women * women who are breastfeeding * prisoners * cognitively impaired requiring legally authorized representative (lar) or power of attorney (poa) * unable to swallow oral capsules

Keywords: hip replacement knee replacement randomized trial acetaminophen post-op pain management
study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of e/c/f/taf fixed dose combination (fdc) in hiv-1 infected adults on chronic hemodialysis

Conditions: HIV-1 Infection

Summary: the primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (e/c/f/taf) fixed-dose combination (fdc) in human immunodeficiency virus (hiv-1) infected adults with end-stage renal disease (esrd) on chronic hemodialysis (hd).


Eligibility criteria:
key inclusion criteria: * currently on a stable antiretroviral regimen for ≥ 6 consecutive months * plasma hiv-1 ribonucleic acid (rna) concentrations \< 50 copies/ml for ≥ 6 months preceding the screening visit and have hiv-1 rna \< 50 copies/ml at screening * no documented history of hiv-1 resistance to elvitegravir (evg), emtricitabine (ftc), lamivudine (3tc) or tenofovir (tfv) and no history of switching off evg, ftc, 3tc or tfv due to concern for resistance * cluster determinant 4 (cd4+) t cell count ≥ 200 cells/μl * esrd with estimated glomerular filtration rate (egfr) \< 15 ml/min by cockcroft-gault formula for creatinine clearance * on chronic hd for ≥ 6 months prior to screening * adequate hematologic function (absolute neutrophil count ≥ 1,000/mm\^3; platelets ≥ 50,000/mm\^3; hemoglobin ≥ 8.5 g/dl) key exclusion criteria: * hepatitis b co-infection * any clinical history, condition, or test result that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements * administration of other investigational agents (unless approved by gilead sciences). participation in any other clinical trial, including observational trials, without prior approval from the sponsor is prohibited while participating in this trial. * history or presence of allergy or intolerance to the study drugs or their components * a new acquired immunodeficiency syndrome (aids)-defining condition (excluding cd4+ t cell count and percentage criteria) diagnosed within the 30 days prior to screening, with the exception of oropharyngeal candidiasis * received solid organ or bone marrow transplant note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: end stage renal disease hemodialysis open-label hiv-1 infection
prediction of glycemic response study

Conditions: Glycemic Response

Summary: the purpose of progress is to engage and intensively monitor 1000 individuals' dietary intake, activity levels, and continuous glucose values over 10 days, link to clinical events out to 3-years, and use that data along with genomic, microbiome, electronic health record (ehr), and other biomarker data to develop a predictive model of individual glucose responses to nutrient intake in individuals with and without type 2 diabetes.

interested individuals will be directed to download the mydatahelps™ (careevolution) mobile app to register and provide informed consent as well as prompt completion of surveys, share their electronic health record data and link the digital health technologies to be used in the study. participants may be asked to schedule an initial virtual meeting (telephone or videoconference) with the research coordinator who will welcome and walk them through the study. once a participant has completed on-boarding, they will be asked to fill out a baseline health, lifestyle, and medical history surveys and, upon completion, invited to request a biosamples study kit to be delivered to their home. this biosamples kit will include: * salivary kit for genomics analysis * gut microbiome kit * home micro-puncture single-use blood collection additional study materials and devices include: * a wrist-worn activity, heart rate and sleep monitor. * a dexcom 6 continuous glucose monitor (cgm) and application kit * a standardized snack bar meal (2 per fasting days) participants will be asked to track various digital health measures including their continuous glucose as well as record their meals for a 10-day period. the data connections approved by the participants will continue in the following years.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. exclusion criteria: * type 1 diabetes mellitus * unable to participate in or comply with any of the testing modules asked during the study * currently pregnant * prior bariatric surgery * chemotherapy or radiation treatment for cancer in the past year * inflammatory bowel disease * known skin allergy to adhesives and nickel (or other contraindications to continuous glucose monitoring) * currently taking any oral steroids(these medications may impact glucose levels) * antibiotic use in the last 3 months prior to the start of the study or planned use during the duration of the study * non-dietary, supplemental probiotic use either daily or weekly * hospice care * end stage renal disease

Keywords: type 2 diabetes
tpf induction with concomitant chemoradiation to treat patients with head and neck cancer

Conditions: Head and Neck Cancer

Summary: the purpose of this trial is to compare two different treatments for fit patients with head and neck cancer: all patients are given induction-chemotherapy (docetaxel, cisplatin, 5-fu). subsequently patients are being randomised into two groups: * the first group receives neo-adjuvant chemotherapy ('high' dose cisplatin) and conventional radiotherapy * the second group receives neo-adjuvant chemotherapy ('low' dose cisplatin) and accelerated radiotherapy.

induction chemotherapy tpf(arm a and b) : docetaxel 75 mg/m2 iv on day 1, cisplatin 75 mg/ m2 iv on day 1, 5-fu 750 mg/ m2/day iv continuous infusion (in hickman or port a cath) on days 1-5; prophylactic g-csf this cycle will be repeated every 21 days for a maximum of 4 cycles. clinical evaluation after each cycle and radiological evaluation after 2 cycles will take place. in case of pd or sd (after 2 cycles) with no minor response (no decrease in measurable disease from baseline) concomitant chemoradiotherapy will started per protocol. surgery the investigators in each centre can decide neck surgery for residual tumor

Eligibility criteria:
inclusion criteria: histology and staging disease * histologically or cytologically proven non-metastatic locally advanced hnscc, stage iii or iv, for which concomitant chemo-radiotherapy would be the standard therapy * patients can be included either with irresectable disease or for which the concomitant chemoradiotherapy was chosen for organ preservation * measurable disease * primary site: oral cavity, oropharynx, hypopharynx and larynx general conditions * written informed consent * age \>18 years and ≤ 65 years * who performance status 0-1 * adequate bone marrow function (wbc \> 3.0 x 109/l, platelets \> 100 x 109/l, hb \> 6 mmol/l) * adequate hepatic function: total bilirubin \< 1. 5 x upper normal limit, asat and alat \< 2.5 x upper normal limits * adequate renal function: calculated creatinin clearance \> 60ml/min. (cockcroft-gault formula) other * expected adequacy of follow-up. exclusion criteria: general conditions * active alcohol addiction * admission for copd in the last 12 months * weight loss \> 10% in 3 months before entry * pregnancy or lactation * patients (m/f) with reproductive potential not implementing adequate contraceptives measures prior or current history * prior surgery, radiotherapy or chemotherapy for this tumor * serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or likely to interfere with the study assessments * serious active infections * other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin concomitant treatments * concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation * concurrent treatment with any other anti-cancer therapy

Keywords: hnscc neo adjuvant chemoradiation therapy tpf
hypofractionated wppt with hdr boost

Conditions: Prostate Cancer

Summary: this is a phase ii study of ultrahypofractionated whole pelvis proton therapy with brachytherapy boost for patients with high risk or unfavorable intermediate risk prostate with elevated risk of lymph node involvement.


Eligibility criteria:
inclusion criteria: * pathologic evidence of prostate cancer * risk group: high or intermediate risk as defined below * high risk: t3a or gleason grade group 4/5 or psa \>20 * unfavorable intermediate risk disease: at least one or more of the following: t2b-t2c, gleason grade group 2/3, psa 10-20, \>50% of cores positive * must be appropriate for whole pelvis per the treating oncologist or based on lymph node predicting nomogram * patient is a candidate for definitive external beam radiotherapy: * no prior radiotherapy in the region of study * no inflammatory bowel disease, active collagen/vascular/connective tissue disorders * age ³18 years * ecog performance status: 0-2 * patients may initiate androgen deprivation therapy up to 3 months prior to radiation start, concurrently, or up to 3 months after completion of radiation therapy start. patients may have received androgen deprivation therapy for the following months: unfavorable intermediate risk patients for 6 months; high-risk patients for 24 months. patients will be allowed to discontinue adt at physician and patient discretion. * pretreatment evaluation * history \& physical by a radiation oncologist within 6 weeks of enrollment * mri prostate * psma pet * psa level * eligible for rectal spacer procedure as determined by treating physician * informed consent: patients must have the ability to understand and be willing to sign the study-specific informed consent indicating their understanding of the investigational nature and the risks of this study before any of the protocol related studies are performed (this does not include routine laboratory testing or imaging studies required to establish study eligibility); exclusion criteria: * evidence of distant metastatic disease * history of inflammatory bowel or active collagen/vascular/connective tissue disorders * prior radiation to the pelvis * prior or concurrent second invasive malignancy other than non-melanoma skin cancers, unless disease free for minimum of five years * known severe, active co-morbidity, defined as follows: o any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the principal investigators, would interfere in the safe and timely completion of study procedures, compromise the patient's ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or results. * patients should not have a prior history of turp * patients should not have pre-treatment ipss \>20 or on maximum alpha-blocker medications at baseline * patients should not be on therapeutic anticoagulation
online cognitive behavior therapy for comorbid sleep problems in alcohol use disorder

Conditions: Alcohol Use Disorder; Insomnia; Sleep Disorder; Dyssomnias

Summary: the main goal is to study the effects of internet-delivered cognitive behavioural therapy with minimum guidance for comorbid sleep problems in alcohol use disorder, in routine addiction care.

alcohol use disorder (aud) is highly prevalent and a major contributor to the global burden of disease. insomnia symptoms are very common among individuals with aud, including those in recovery, which may in turn promote alcohol relapse. specialization and silo phenomena in healthcare organization, separating addiction from other types of psychiatric care, means that individuals with aud and comorbid sleep problems often have difficulty accessing evidence-treatment for the latter. offering online treatment for sleep problems to individuals enrolled in traditional routine addiction care is an attractive and pragmatic approach to offering parallel treatments covering the full clinical presentation, which has not yet been evaluated. this pilot and feasibility trial will recruit n=25 from patients in routine addiction care with comorbid sleep problems and aud, who will complete an online, ten-module, cbt-based treatment program with minimum guidance for sleep problems, tailored for individuals with aud.

Eligibility criteria:
inclusion criteria: * enrolled patient at stockholm center for dependency disorders * diagnosed alcohol use disorder * self-rated sleep problem exclusion criteria: * addiction to sedative or hypnotic medication * psychoactive medication not yet 3-month stable in dose * bipolar disorder * psychotic disorder * suicidality * periodic limb movement disorder (plmd) * sleep apnea
efficiency of using osseodensification protocol

Conditions: Alveolar Bone Resorption

Summary: the goal of this clinical trial is to learn if the new osseo-densification technique works to provide enough bone width and quality prior to implant placement in the upper jaw the main question it aims to answer is: is the use of osseo-densification protocol better than the standard alveolar ridge widening techniques; regarding efficiency and comfort in obtaining sufficient alveolar ridge width in horizontally atrophic alveolar ridges?

a new osseo-densification protocol using specially designed densah burs was compared to conventional hand osteotome technique to test its efficiency in providing sufficient bone quantity and quality in cases of horizontally deficient maxillary edentulous alveolar ridge sites that require expansion prior to dental implant placement

Eligibility criteria:
inclusion criteria: * age ≥18 years old. * in cases of an initial ridge width ≤ 5mm that contains ≤ 2mm of trabecular bone core. * alveolar ridges with narrow crest and wider base. exclusion criteria: * uncontrolled diabetic patients * heavy smokers * patients suffering from osteoporosis * patients receiving chemo or radio therapy * patients suffering from bleeding disorders * patients suffering from intraosseous lesions at the proposed site of implant * patients with insufficient alveolar bone hight less than 10 mm. * resorbed ridge with a narrow base.

Keywords: densah burs osseodensification osseohand osteotomes alveolar ridge wideninig